Corporate news

Statement concerning medical devices used for veterinary applications 

By: Mölnlycke Health Care, February 9 2015Posted in: Corporate news

Mölnlycke Health Care product ranges are predominantly* designed and regulated for human use.  Any use of our product range on animals needs to authorised and carried out by suitably qualified Animal Health Care professionals and in accordance with any applicable instructions for use.

We confirm that all of our products have been manufactured to the standards of a Quality Management System certified to ISO 9001 and ISO 13485. The Quality Management System includes quality control, materials control, in process controls, final product quality control, and full batch control.

Our sterile products have been sterilised by a validated process.

Any questions regarding use of products on animals should be directed to your local sales representative or our customer service team.

Caroline Allen

Director of Regulatory Affairs (Global Operations)

Global Quality and Regulatory Affairs Group

*We currently have a small number of procedure trays and kits that are designed for use on animals.  Procedure trays designed for this purpose are currently not subject to any specific regulation within Europe and as such do not carry the CE mark.

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